Dexbrompheniramine/pseudoephedrine

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Dexbrompheniramine/pseudoephedrine
Combination of
Dexbrompheniramine Antihistamine
Pseudoephedrine Decongestant
Clinical data
Trade names Drixoral
AHFS/Drugs.com Micromedex Detailed Consumer Information
Pregnancy
category
  • US: C (Risk not ruled out)
ATC code
Legal status
Legal status

Dexbrompheniramine/pseudoephedrine (trade name Drixoral) is a combination medication that contains the antihistamine dexbrompheniramine maleate and the decongestant pseudoephedrine sulfate. It was manufactured by Schering-Plough and was used to treat symptoms associated with allergies and colds such as itchy and watery eyes, runny nose, nasal and sinus congestion, and sneezing. Because it contains pseudoephedrine, its purchase in the United States was severely restricted by the Combat Methamphetamine Epidemic Act of 2005 over fears that any product containing pseudoephedrine can be used to make methamphetamine.[1]

As of 2008, Drixoral has been completely removed from the US market by manufacturer Merck (formerly Schering-Plough). The company's updated website attributes "changing [their] manufacturing location" for the supply disruption and currently states "it is unlikely product will be available in 2010".[2] However, the drug still appears to be available in Canada and overseas,[3][4] and other drugs manufactured at the same location have not become unavailable. This has led some Drixoral users to speculate that there may be other explanations for why Drixoral is no longer available in the US market. One possible reason is that the company is reformulating the product to no longer contain pseudoephedrine. Another possibility is that the 35-year-old drug is being removed in favor of newer, more profitable antihistamines such as Claritin (also manufactured by Schering-Plough).

Some Drixoral users have resorted to ordering the drug from Canadian online pharmacies or from a generic substitute manufactured for the Turkish market. The drug was removed from the Turkish market in 2012. In 2015, Drixoral was also removed from the Canadian market, after Merck sold off their OTC business to Bayer, who is no longer making the original Drixoral tablets. Bayer continues to make a line of nasal sprays under the Drixoral name, but its active ingredients are not what was in the Drixoral tablets.

Since 2015, many allergy sufferers have searched compounding pharmacies in an attempt to replicate the original tablet formulation of Drixoral. However, few, if any compounding pharmacies have been able to obtain the pseudoephedrine component in sufficient quantities to approach any meaningful order fulfillment. The other component active in Drixoral, dexbrompheniramine maleate, has been proven scarcely available. For the prolonged, or longer lasting antihistamine/decongenstant relief that many allergy suffers pursued, Drixoral included the now popular 12-Hour timed release tablet formulation, or coated process of ingredient dissemination. The patented timed release tablet formulation is another process that has proven tricky for many a compounding pharmacy to exactly replicate. Yet, while the precise Drixoral tablet replication remains somewhat elusive, the pairing of the two active ingredients in Drixoral, pseudoephedrine and dexbrompheniramine maleate, remains possible, though in a less timed-release form.

A small Alabama based pharmaceutical company known as Poly Pharmaceuticals markets the dexbrompheniramine maleate component under the name "Ala-hist IR", which can be purchased directly from their website (www.alahist.com).[5] The 2mg tablet Ala-hist IR form of the major Dixoral antihistamine ingredient dexbrompheniramine maleate, comprises one third of the 6mg timed release dosage of the Drixoral tablet. Thus, it is possible to use the 12-Hour timed-release Sudafed tablet, the most widely available tablet containing the same 120mg Drixoral dosage of pseudoephedrine, along with the Ala-hist IR 2mg tablet in three separate steps (one 2mg tablet every 4 hours), to obtain a similar delivery originally found in the Drixoral Cold & Sinus formulation.

References[edit]

  1. ^ Payne, January W. (March 9, 2009). "Drixoral: Why the Allergy Medicine Isn't Available, and What to Use Instead" (html). U.S. News and World Report. Retrieved 2010-02-22. 
  2. ^ "Products Currently Unavailable" (html). Merck. 2010. Retrieved 2010-05-18. 
  3. ^ "Drixoral Canada" (html). Schering Plough. 2010. Retrieved 2010-02-22. 
  4. ^ "Buy Drixoral" (html). Canada Medicine Shop. 2010. Retrieved 2010-02-22. 
  5. ^ https://alahist.com/